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Clinical Study to Assess Safety, PK and PD Parameters of CDR132L

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045405
Recruitment Status : Active, not recruiting
First Posted : August 5, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Cardior Pharmaceuticals GmbH

Brief Summary:
This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: CDR132L Phase 1

Detailed Description:

Objectives:

Primary

• To assess the safety of one single and one repeated dose of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Secondary • To characterize the pharmacokinetic (PK) profile of CDR132L in patients with stable heart failure of ischemic origin.

Exploratory

• To determine the effect of CDR132L on pharmacodynamic (PD) parameters.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess Safety, PK and PD Parameters of CDR132L in Patients With Stable Heart Failure of Ischemic Origin (NYHA 1- 3)
Actual Study Start Date : June 21, 2019
Actual Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CDR132L Drug: CDR132L
i.v. administration

Placebo Comparator: Saline Drug: CDR132L
i.v. administration




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [safety and tolerability] [ Time Frame: 4 months ]
    The incidence and severity of treatment-emergent adverse events (TEAEs)


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 4 months ]
    Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)

  2. Time to reach maximum plasma concentration (Tmax) [ Time Frame: 4 months ]
    Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)

  3. Area under the curve (AUC0-t) [ Time Frame: 4 months ]
    Pharmacokinetics parameter area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t)

  4. Area under the curve (AUC0-inf) [ Time Frame: 4 months ]
    Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)

  5. Blood clearance (CL) [ Time Frame: 4 months ]
    Pharmacokinetics parameter to determin clearance considering terminal elimination rate

  6. Half life (t1/2) [ Time Frame: 4 months ]
    Pharmacokinetics parameter to determin half-life rate (t1/2)

  7. Volume of distribution (Vdss) [ Time Frame: 4 months ]
    Pharmacokinetics parameter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable heart failure of ischemic origin

Exclusion Criteria:

  • Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045405


Locations
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United Kingdom
Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Cardior Pharmaceuticals GmbH
Investigators
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Study Director: Wilfried Hauke, MD MFPM Cardior Pharmaceuticals GmbH CMO
Principal Investigator: Jorg Taubel, MD FFPM Richmond Pharmacology Ltd CEO

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Responsible Party: Cardior Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT04045405    
Other Study ID Numbers: CDR132L-FIH01
2019-001291-10 ( EudraCT Number )
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases